EU Manufacturer
๐ฉ๐ช Germany
Active
G. Heinemann Medizintechnik GmbH
SRN: DE-MF-000009705
ยท
Leibnizstr. 13-15, 24568 Kaltenkirchen, Germany
Basic UDI-DIs
11
Total Devices
16
On Market
16
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
28
Basic Information
- Address
- Leibnizstr. 13-15, 24568 Kaltenkirchen, Germany
- [email protected]
- Phone
- +49 4191 95 379 0
- Website
- www.heinemann-ent.de
Regulatory Overview
Regulation
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Eu Mdd
10
Eu Mdr
1
Classification
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Eu Md Class 2a
11
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | 1224DE414200331 | DNV MEDCERT GmbH | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 28 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ENT treatment unit MODULA Duo | EU MDR | Eu Md Class 2a | On Market | 0 |
| ENT treatment unit MODULA Europa | EU MDR | Eu Md Class 2a | On Market | 0 |
| ENT treatment unit MODULA Mini | EU MDR | Eu Md Class 2a | On Market | 0 |
| ENT treatment unit MODULA Paris | EU MDR | Eu Md Class 2a | On Market | 0 |
| ENT treatment unit MODULA-L | EU MDR | Eu Md Class 2a | On Market | 0 |
| ENT treatment unit MODULA-M | EU MDR | Eu Md Class 2a | On Market | 0 |
| IMPEDANCE METERS FOR THE AUDITORY SYSTEM | EU MDD | Eu Md Class 2a | On Market | 1 |
| IMPEDANCE METERS FOR THE AUDITORY SYSTEM | EU MDD | Eu Md Class 2a | On Market | 1 |
| OTO-CALORIC STIMULATORS | EU MDD | Eu Md Class 2a | On Market | 1 |
| OTOACOUSTIC EMISSIONS EQUIPMENT | EU MDD | Eu Md Class 2a | On Market | 1 |
| RHINOMANOMETERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| RHINOMANOMETERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| ULTRASOUND SCANNERS - OTHER | EU MDD | Eu Md Class 2a | On Market | 1 |
| VARIOUS ENT INSTRUMENTS - OTHER | EU MDD | Eu Md Class 2a | On Market | 1 |
| VARIOUS ENT INSTRUMENTS - OTHER | EU MDD | Eu Md Class 2a | On Market | 1 |
| VIDEO/ELECTRONYSTAGMOGRAPHS | EU MDD | Eu Md Class 2a | On Market | 1 |